Study On Efficacy And Safety Of Chaihu Anxin Capsule In Cardiac Neurosis

Objective: Cardiac neurosis is a frequent disease in the cardiology clinic, which is associated with body constitution, nerves, behavior, environment, and heredity. However, there is no evidence organic heart disease. The symptoms of cardiac neurosis are highly variable and durable. During seeking the treatment for cardiac neurosis, most of the patients find it very difficult to cure after many attempts. Generally, modern western medicine is lacking efficacy in curing this disease, because of many drawbacks: severe side effects, poor patients'adherence, and high rate of recurrence. Conversely, Traditional Chinese Medicine has many advantages over Western Medicine due to its features of differentiation of symptoms and signs to treat. According to the theory of Traditional Chinese Medicine, unfolding liver and gloomy, calming the adverse-rising energy, making lucid yang rise and turbid yin descend is the key point of the treatment.We designed this study to determine the efficacy and safety of chaihu anxin capsule in cardiac neurosis.Methods: From July 2005 to December 2006, we enrolled sixty cardiac neurosis patients in our hospital. The including criteria were unspecific body and nerve symptoms, such as chest pain, chest distress, palmus, dizziness, insomnia, dream, short breath, suffering breathing obstruction, sigh. However, there was no evidence of organic heart disease. Or diagnosed with melancholia according to differentiation of symptoms and signs of traditional Chinese medicine is stagnation of QI due to depression of the liver, yingqi and weiqi out of tune and being unpeaceful in mind. The total score of symptom of grade quantization standard reached at least 6, and, at the same time, with anxiety or depression disorder diagnosed with Hamilton anxious and depression scale.Exclusion criteria were: coronary heart disease, angina pectoris, hypertension, arteria basilaris disease, ischemic brain disease, organic upper digestive tract disease, organic nerve disease and mental disorders, severe heart and lung functional defect, arrhythmia, severe primary liver disease, primary kidney disease, primary hematopoietic system disease, pregnancy or lactation femme, hypersensitiveness constitution or hypersensitive with sorts of drugs in the capsule. In total, 102 patients (32 male and 70 female) were enrolled in the study.They were randomized into chaihu anxin capsule group and Dailixin group. The patients in chaihu anxin capsule group were given chaihu anxin capsule orally (2-4 pills, ter in die), whereas the patients in dailixin group took dailixin orally (one pill in morning and another in the noon). For those with rapid heart rate, metoprolol or propanolol was given. If there were any severe side effects or complications, participants could discontinue the drugs they took.The data of blood pressure, heart rate, electrocardiogram and been tested blood, urine and suitable routine, liver and renal function, score based on Chinese medical science symptom grade quantization reference, Hamilton anxiety scale (HAMA) and Hamilton depression scale (HAMD) were collected at baseline. We assessed the symptoms, score based on Chinese medical science symptom grade quantization reference, Hamilton anxiety scale (HAMA) and Hamilton depression scale (HAMD) at week 1, 2, 3 and 4 respectively. All the safety data were also collected at week 4.All statistical analyses were performed with two-sided alternatives and a typeⅠerror of 0.05 and with SAS software (version 6.12). Initially the homogeneity of variance among all the groups was analyzed. All the data were expressed as mean±standard deviation (mean±SD) and students t test was used to explore statistical significance. Chi-square test was used for analysis of categorical data.Results: 1 We enrolled 102 patients (32 males and 70 females) in total. Eight patients'age ranged 18 to 29; fourteen patients aged between 30~39; twenty nine patients was between 40 to 49 years old; thirty six patients were aged between 50 to 59; fifteen patients'age were between 60 to 65. Seventy nine patients presented with anxiety, making up 77.45 % in the population. Nine patients'major presentation was depression, making up 8.82% of the population. Fourteen patients presented with anxiety-depression, making up 13.73% of the population. All patients accomplished the follow up. There were no death and drop out during the study period.2 The clinical characteristics of the two groups matched well. Compared with baseline, there was no significant changes in the blood pressure, heart rate, blood, urine and suitable routine, liver and renal function after treatment (p>0.05).3 After 28-days treatment, the total effective rate was 100% in chaihu anxin capsule group and 92% in dailixin group. There was no significant difference between two groups (X2=2.467 P=0.116>0.05, Fig 1, table 1).4 Both chaihu anxin capsule and dailixin could significantly improved the symptoms of the Chinese medical science symptom score in patients with cardiac neurosis(P<0.001).Similar therapeutic effects occurred in HAMA and HAMD score (P<0.001,table 2,3,4,5,6,7 fig1,2,3).5 There was a trend that both both chaihu anxin capsule and dailixin could lower the score in Chinese medical science symptom grade quantization reference, however, there was no significant statistical difference (table 2, fig 1). But, the data showed chaihu anxin capsule had more effects at week 2 and week 3, compared with dailixin group, suggestive of chaihu anxin had more rapid therapeutic effects (table 7).6 Compared with dailixin, chaihu anxin capsule significantly improved the symptoms in patients with cardiac neurosis according to Hamilton anxiety scale in whole study period (4.75±1.64vs6.98±1.67;t=3.24 P=0.0016, fig 2, fig 3).7 As compared with baseline, both chaihu anxin capsule and dailixin had a trend to lower the score in Hamilton depression scale, however, there was no significant difference (P >0.05, fig 4, fig 5). This trend persisted the whole study period (fig 7).8 Both chaihu anxin capsule and dailixin had no impact on liver and renal function. After 28-day treatment, there were no significant changes in ALT, AST, BUN, CRE.9 Safety profile: There were no side effects reported during the study period.Conclusions: 1 The efficacy rate of chaihu anxin capsule in treatment of Cardiac neurosis was 100%, which was superior over anti-depression and anti-anxiety drug dailixin. There were no side effects documented in the study period. Thus, it maybe a promising drug with good safty profile.2 As compared with dailixin, chaihu anxin capsule could significant improve the symptoms of patients who presented with anxiety, unspecific body and nerve symptoms. However there was no significant difference between two drugs in cardiac neurosis prestented with depression.3 Our data also showed that most of patient with cardiac neurosis presented in the clinic with anxiety.